MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ROBI KELLY FORCEPS INSERT

Model Number	38610MD
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgical procedure, the bipolar forceps malfunctioned, failing to perform coagulation effectively.The device suddenly stopped working, even after checking the connection to the electrosurgical unit and attempting to restart it.It was necessary to replace it with another bipolar forceps to continue the surgery without compromising the procedure.The failure consisted of a complete interruption of the coagulation function.No negative impact in state of health reported.Cross reference mdr: 9610617-2025-01560, 9610617-2025-02343.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.Additional information: devices reported for this case: 201066694, 38610md robi kelly forceps insert batch: wl28 leading device: causal for failure according to investigation results.201066695, 38610md robi kelly forceps insert batch: wl28 leading device: causal for failure according to investigation results.201066700, 38610md robi kelly forceps insert batch: tl03 leading device: causal for failure according to investigation results.201066696, 38600 robi metal outer sheath batch: wl08 involved device: causal for failure according to investigation results.201066697, 38600 robi metal outer sheath batch: wl08 involved device: causal for failure according to investigation results.201066698, 38151 robi plastic handle batch: yl16 involved device: causal for failure according to investigation results.201066699, 38151 robi plastic handle batch: yl16 involved device: causal for failure according to investigation results.Analysis of the available information indicates that the cause of the malfunction is most likely due to user error.The following points support this assumption: the affected product was not returned for inspection, making technical analysis impossible.There are three complaints relating to two different batches.This argues against a systematic problem.All items were checked before storage, and the test batch was unremarkable.Possible causes of the malfunction: incorrect handling, e.G., incorrect parameters or activating the hf switch for too long.Incorrect preparation, e.G., residual moisture that could lead to a short circuit.Cross reference complaint id: (b)(4).The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ROBI KELLY FORCEPS INSERT
• Common Device Name: ROBI KELLY FORCEPS INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 23823596
• Report Number: 9610617-2025-02342
• Device Sequence Number: 15774419
• Product Code: GEI
• UDI-Device Identifier: 04048551328682
• UDI-Public: 04048551328682
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K962030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 38610MD
• Device Catalogue Number: 38610MD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/16/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTICLE:38151 ROBI PLASTIC HANDLE. LOT: YL16.; ARTICLE:38151 ROBI PLASTIC HANDLE. LOT: YL16.; ARTICLE:38600 ROBI METAL OUTER SHEATH.LOT: WL08.; ARTICLE:38600 ROBI METAL OUTER SHEATH.LOT: WLO8.
• Patient Sex: Unknown